NON-INTERVENTIONAL RETROSPECTIVE EVALUATION OF TOLERABILITY AND EFFICACY OF TYPICAL ORAL LONG-ACTING WHO-STEP III OPIOID ANALGESICs UNDER REAL-WORLD CONDITIONS IN PATIENTS SUFFERING FROM (LOW) BACK PAIN AFTER FAILURE OF A PREVIOUS TREATMENT WITH EITHER NONOPIOID, MILD OR STRONG OPIOID ANALGESICS (123TOWHO3)

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Non-randomised clinical trial

Population studied

• Short description of the study population:
  Patients with low back pain (LBP) who were previously treated with either nonopioids (group 1), mild (group 2) or strong opioid analgesics (group 3) under conditions of routine clinical practice.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Low back pain patients
• Estimated number of subjects:
  756

Study design details

• Main study objective:
  To assess differential treatment effects reported by patients who were switched to the target treatment after failure of a treatment with either a) nonopioids, b) mild opioids, or c) strong opioid analgesics.
• Outcomes:
  Percentage of patients in all 3 treatment groups who fulfilled the criteria of an aggregated5-factor symptom score (ASR-5), defined as a composite of four efficacy parameters (>=50% improvement of pain, pain-related disabilities, clinical phenomenology, and quality-of-life) and one tolerability parameter (>=12mm VAS worsening of the bowel function index). Percentage of patients in all 3 treatment groups who fulfilled at least three out of the fivecriteria of the ASR-5. Further analyses focus on treatment-related changes of pain intensityand associated parameters relevant for daily life functioning, quality-of-life, clinical painphenomenology, concurrent analgesic treatments, bowel function and adverse events.
• Data analysis plan:
  Exploratory analysis of anonymized 12-week routine/open-label data provided by theGerman Pain e-Registry (GPR) on adult LBP patients, in whom a treatment with strong, oral, long-acting WHO-3 opioid has been initiated in compliance with the current German prescribing regulations before December 31, 2018. LBP-patients who were switched to these treatments after failure of nonopioids were defined as group 1, those switches from mild opioids were defined as group 2 and those rotated from other strong opiods were defined as group 3. a propensity score analysis will be performed to select patients in groups 1-3 comparable to those in a previous trial performed with the atypical opioid tapentadol (WHO123TOTAP).No formal sample size analysis will be performed. Data analyses will be performed for allpatients identified through the aforementioned selection proces